Over two editions of the NYRB, Harvard’s Marcia Angell, former editor of the New England Journal of Medicine, examines the ‘epidemic of Mental Illness’ in modern America as well as ruminating on the implications of the next edition of DSM, the industry bible at the heart of the prescription culture.

1987 – 2007 saw the numbers qualifying for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increase nearly 2.5 times (1/184 in 1987 to 1/76 by 2007). In children the rate of increase was even more rapid: 35 times greater. Mental Illness is now the leading cause of disability in children, well ahead of physical disabilities..for which the Federal Programs were created.

Treatment of mental illness is nearly always by psychoactive drugs. Most psychiatrists treat only with drugs, referring patients to psychologists or social workers if they believe psychotherapy is also needed. The shift from ‘talk’ to ‘drugs’ mirrors the shift to belief that mental illness is the result of chemical imbalance. A theory rooted in the marketing of Prozac in 1987. In the following decade the number of people treated for depression tripled. (A)bout 10 percent of Americans over age six now take antidepressants. Antipsychotics are now the top-selling class of drug in the USA.

Kirsch, Whitaker & Carlat agree ‘on the disturbing extent to which the companies that sell psychoactive drugs…have come to determine what constitutes a mental illness and how the disorders should be diagnosed and treated’. They also all dispute that mental illness is caused by a chemical imbalance in the brain.

Between 1954 & ’57 three drugs were launched to treat the then ‘three major categories of mental illness’ – psychosis (Thorzine / chlorpromazine), anxiety (miltown / meprobamate) and depression (iproniazid)… ‘and the face of psychiatry was totally transformed’. Initially developed to treat physical disorders each drug was found to calm (for psychosis and anxiety) or lift (for depression) mental states as a side effect. Research showed these, and their successors, were affecting the level of chemicals in the brain and the neurotransmitter levels (the alteration of which can be detected by analysis of spinal fluid) which are known to allow communication within the brain. From this a causal link was established:

This instead of developing a drug to treat an abnormality, an abnormality was postulated to fit a drug.… it was entirely possible that drugs that affected neurotransmitter levels could relieve symptoms even if neurotransmitters had nothing to do with the illness in the first place. Carlat puts it starkly – if pain relief was treated the same way then Opium would be mass prescribed since narcotic pain medications activate opiate receptors in the brain… and we would believe that fevers are caused by too little aspirin.

However more damming is the fact that 50 years of seeking to prove the chemical basis of mental disorder has produced nothing to substantiate it. Neurotransmitter function seems to be normal in people with mental illness before any treatment… there is no chemical ‘imbalance’ until you start taking medication.

That there is no science to prove the basis for medicating is of interest but less point if the drugs actually work. Kirsch’s book seeks to ask that very question for antidepressants. His 15 year study at Hull University started by examining 38 published clinical trials. These showed that placebo’s were 3 times more effective in treating depression than no treatment at all. However antidepressants were only 4 times more effective. Placebos were 75% as effective as antidepressants. Kirsch then looked at unpublished trial records of the FDA.

To gain FDA approval for a drug all clinical trials must be submitted. If two of these trials show a drug to be more effective than a placebo then, generally, a drug will be approved. The number of failed trials is irrelevant and unpublished and classified as confidential proprietary information. Kirsch used Freedom of Information legislation to attain the unpublished trials for the six most widely used antidepressants (between 1987 and ’99) – Prozac, Paxil, Zoloft, Celexa, Serzone & Effexor. In total there were 42 trials. The majority were negative – they failed to show the drug more effective than a placebo. Overall placebos were 82% as effective as the drugs. On the Hamilton Depression Scale (a score of the symptoms of depression widely used by the profession) the average difference between the drug and the placebo was 1.8 points ‘ a difference that, while statistically significant, was clinically meaningless. All drugs were equally unimpressive in their effectiveness..yet because the positive tests were widely publicised the public and medical profession came to believe the drugs highly effective’.

In addition Kirsch found other drugs not considered antidepressants (synthetic thyroid hormone, opiates, sedatives, stimulates and some herbal remedies) as effective as antidepressants. The ‘chemical’ impact – serotonin levels – was irrelevant to effectiveness.

A placebo was 75-82% as effective; another drug – one with side effects that a placebo lacks – was as effective as the prescribed medication. This matched with the accepted feeling that antidepressants were more effective for severe depression cases – severe cases are given heavier antidepressants and thus the side-effects are more pronounced. Tests using ‘active’ placebos (ones producing side effects) bore this out – there was no difference in effectiveness between the antidepressant and the active placebo. Kirsch is a faithful proponent of the scientific method, and his voice therefore brings a welcome objectivity to a subject often swayed by anecdotes, emotions or self-interest.

Depression and schizophrenia has changed. Before they were episodic and self-limited – characterised by long periods of normalcy between bouts. Now they are chronic and lifelong and Whittaker purports this as due to the long-term effects of the drugs prescribed to treat them. As a journalist rather than scientist his work is less rigorous than Kirsch’s but cites some important relevant authorities – Steve Hyman supports his assertion that long-term use of psychoactive drugs causes ‘substantial and long-lasting alterations in neural function’. These effects, the side-effects of the drugs and of the drugs needed to treat the side-effects result in daily cocktails of medication and increase the difficulty of getting off medication. Removal of medication often doesn’t ‘restore’ the pre-existing ‘balance’ of the brain but rather leaves it unable to compensate for the sudden lack or surfeit of the ‘treated’ chemical. Whitaker is furious at this iatrogenic epidemic as well as at the huge impact that the medications side-effects, physical and mental, have had on the population.

Before drugs were introduced the profession had little interest in neurotransmitters or any other aspect of the physical brain. Prior to the mid-50s drug ‘revolution’ Freudian conflict was seen as the source of mental illness – this was illness of ‘the mind’ rather than ‘the brain’. From the 50s to the 80s psychiatrists became psycho-pharmacologists – concerned less with life-story and more with reducing symptoms of ‘chemical imbalance’. As early as the ‘70s an anti-psychiatry movement took root, alarmed by the side-effects and the profession was in competition for resources from social workers. In addition there remained firm adherents to the Freudian / mind tradition. The result was the American Psychiatric Association’s (APA) ‘vigorous effort to remedicalize psychiatry’ (Melvin Sabshin, Medical Director APA) via the MD’s weapon of choice – the prescription script. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also able to identify itself as a scientific discipline’. The pharmaceutical industry soon made its gratitude tangible.

The device to enforce the biological model was the DSM – the book providing the diagnostic criteria for all mental disorders. The first two editions of the book (1952, 1968) were Freudian endeavours. DSM-III was pure ‘chemistry’. Published in 1980 it contained 265 diagnoses (83 more than DSM II) and was deliberately marketed not only to the medical profession but insurers, judges, lawyers, companies, hospitals, prisons, govt. agencies and any bodies concerned with citizens well-being. Consistency of diagnosis (reliability) was the key and matching diagnosis to drug the goal –see 2010 speech by APA president Carol Bernstein. Reliability is NOT the same as validity. The problem of the DSM is that in all of its editions it has simply reflected the opinions of its writers. DSM-III has been heavily criticised as being the opinions of the then President of the APA, Robert Spitzer, who staffed its ‘research team’ with people he viewed as yes men. He would later brag ‘I could just get my way by sweet talking and whatnot’. By 1984 George Vailant, professor of psychiatry at Harvard Medical School, claimed DSM-III no more than ‘a bold series of choices based on guess, taste, prejudice and hope’.

DSM-III had no citations of scientific studies to support its decisions; the most recent edition has ‘source-books’ – presenting rationales and limited references. It remains far from being a scientific work referenced with evidence. It may be of much interest for a group of experts to get together and offer their opinions but unless these opinions can be buttressed by evidence they do not warrant the extraordinary deference shown to DSM.

DSM-III’s 265 diagnoses had grown to 365 by the time DSM-IV (TR) was published in 2000. Each new edition has produced a larger more expensive volume to be purchased by all the industries with an interest in the mental health machine. With over 1,000,000 sales its revenue is a major funding source for the APA. And membership of the editorial team has proved lucrative to members of a psychiatric profession already well-financed by pharmaceutical companies. 1/5th of APA funding comes from drug companies and Minnesota & Vermont’s ‘sunshine’ transparency laws have revealed that drug companies pay more money to psychiatrists than any other specialty field. Contributors to the DSM are seen as Key Opinion Leaders for the pharmaceutical industry – of the 170 who worked on DSM-IV-TR, 95 had financial ties to drug companies, including every contributor to the sections on mood disorders and schizophrenia. 56% of the APA members composing the work-groups for the forthcoming DSM-V ‘disclosed significant industry interests’.

Carlat is clear as to why his profession receives so much money from the pharmaceutical industry ‘our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another’. There are no objective signs or tests for mental illness – no lab data or MRI findings – the boundaries from normal and abnormal are unclear – leaving it possible to expand diagnostic boundaries and create new diagnoses that would be impossible in a field like cardiology.

Drug companies don’t limit themselves to funding psychiatrists. The fund patient advocacy groups and educational organisations. In 3 months of 2009 one company, Eli Lilly, gave over $1.2 million to 4 advocacy / patient support groups. These groups influence insurers to cover products and products ensure psychiatrists see more patients per hour than they would if they had to deal it ‘talk’. Carlat believes ‘scripts’ allow him an income of $180 per hour – he estimates he would be under the $100 per hour if he indulged in ‘talk’ therapy. The quick matching of symptoms to disorders leaves most patients with multiple mental health ‘problems’ and multiple prescription medications to treat them (typically Celexa for depression with Ativan for anxiety and Ambien for insomnia and Provigil to combat the fatigue brought on by Celexa and Viagra for the other main side-effect.). In addition he states that within the categories of mental health disorders there is very little difference between the panoply of drugs. ‘To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep’

Work on DSM-V is ongoing and it is clear that DSM-IV-TR’s 365 diagnoses will be expanded on yet again. Even the chair of DSM-IV, Allen Frances, is highly critical of this, claiming it will be a ‘bonanza for the pharmaceutical industry but at a huge cost to the new false positive patients caught in the excessively wide DSM-V net’ (Psychiatric Times, 06/26/09). Certainly the net is going to be cast wide – Kupfer and Reiger, who lead the DSM-V project, made clear they viewed 30-50% of all patients presenting themselves for any primary health care to be displaying ‘prominent mental health symptoms or identifiable mental disorders’. It looks as though it will be harder and harder to be normal.

Of even greater concern is the rise in diagnosis and treatment of mental illness in children as young as two years old. Juvenile bipolar disorder prevalence jumped forty-four fold in 11 years (’93-’04) while autism went from 1/500 to 1/90 over the same period. 10% of US 10yo boys now take daily stimulants for ADHD and 500,000 US kids take antipsychotic drugs. These diagnoses also go through ‘trends’ – ADHD’s pervasiveness was limited in time by the suggestion that many ADHD diagnoses were actually bipolar disorder and that it could be treated at infancy, leading to the rise of juvenile bipolar disorder which in turn has been ‘replaced’ by the ‘new monster’ of TDD (temper dysregulation disorder with dysphoria) which is scheduled to appear in DSM-V.

Two additional problems, welfare-entitlement and off-label prescription, compound the issue of children and mental health medication. David Autor makes clear that a family’s child qualifying for mental health drugs becomes ‘the new welfare’ – the family will be entitled to SSI, more generous than standard welfare, and often Medicare. Hospitals and state welfare agencies have incentives to encourage uninsured families to apply for SSI payments since hospitals will get paid and states will save money by shifting welfare costs to the federal government. Rutgers University found that children from low-income families are four times more likely to receive the qualifying antipsychotic medicines than are privately insured children.

Rebecca Riley died aged 4 from an OD on Clonidine and Depakote which she was prescribed for ADHD and bipolar disorder from diagnoses she obtained when 2 years old. Clonidine was FDA approved for high blood pressure, Depakote for epilepsy and acute mania in bipolar disorder. She was also using Seroquel, approved for schizophrenia and acute mania. None was approved for ADHD or long-term use in treating bipolar disorder; none was approved for use in 4 year old children. Her siblings had similar diagnoses and were taking combination psychoactive drugs. Her family, save herself who was merely in the process of apply for such, were all in receipt of SSI. The family dispute accusations that they over-dosed their children.

It is illegal for companies to market drugs for anything other than their approved use. It is not illegal for physicians to prescribe drugs for anything other than their approved use. In the past four years five firms have admitted to federal charges of illegally marketing psychoactive drugs… despite having to pay hundreds of millions of dollars to settle the charges, the companies have probably come out well ahead. Doctors could prescribe off-label so as to take advantage of new scientific evidence – that sensible caveat has become a marketing tool fit to be exploited by the highly subjective nature of psychiatric diagnosis.

Americans have come to believe that pills are more potent despite psychotherapy (talk) and exercise having been shown to be as effective as drugs for depression. Helping families in troubled economic circumstances should not be dealt with by diagnosing 2 year olds with ADHA and juvenile bipolar disorder – tutoring, after-school care and education would probably be less expensive… ‘but unfortunately there is no industry to push these alternatives’. Rebecca Riley’s father was found guilty of first degree murder and given a life sentence without the possibility of parole, her mother guilty of second degree murder and sentenced to a minimum of 15 years. Her brother and sister are in state care.

QUOTE: ‘I could just get my way by sweet talking and whatnot‘ – Robert Spitzer.